Taiwan FDA registration 382cc347be312359b0f75cf1ea480e8a
"ACRO" Legionella Urinary Antigen Rapid Test (Non-Sterile)
TW: "艾快露" 退伍軍人肺炎尿液抗原快速檢驗試劑 (未滅菌)
Registration details
- Analysis ID
- 382cc347be312359b0f75cf1ea480e8a
- License Form
- Ministry of Health Medical Device Import No. 017030
- Customs Code
- DHA09401703000
Company information
- Manufacturer
- ACRO BIOTECH. INC.
- Manufacturer Country
- United States
- Authorized Representative
- Grand Marquis IVD CO., LTD.
Product details
- Intended Use
- Limit the management method of medical equipment Haemophilus serogenus (C.3300) first level identification range.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3300 Haemophilus serology
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 26, 2016
- Expiry Date
- Sep 26, 2026
About this record
Access comprehensive regulatory information for "ACRO" Legionella Urinary Antigen Rapid Test (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 382cc347be312359b0f75cf1ea480e8a and manufactured by ACRO BIOTECH. INC.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices